FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069508 [Registered on: 26/06/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Problem of Mass coming out of private parts in the women in community. 
Scientific Title of Study   Prevalence of Symptomatic pelvic organ prolapse in Belgavi district, India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rajan R Patil 
Designation  Professor 
Affiliation  J N Medical College, KLE Academy of Higher Education and Research, Belagavi 
Address  Department of Public Health JNMC, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9445811610  
Fax    
Email  rajanpatil@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajandra Nerli 
Designation  Professor 
Affiliation  J N Medical College, KLE Academy of Higher Education and Research, Belagavi 
Address  Department of Urology Dr. Prabhakar Kore Hospital JNMC, Neharu Nagar Belgaum Karnatak

Belgaum
KARNATAKA
590010
India 
Phone  9353940487  
Fax    
Email  rajendranerli@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Rajan R Patil 
Designation  Professor 
Affiliation  J N Medical College, KLE Academy of Higher Education and Research, Belagavi 
Address  Department of Public Health JNMC, Nehru Nagar, Belagavi, Karnataka

Belgaum
KARNATAKA
590010
India 
Phone  9445811610  
Fax    
Email  rajanpatil@yahoo.com  
 
Source of Monetary or Material Support  
University internal seed money for Research by KLE Academy of Higher Education and Research, Neharu nagar, Belagavi 560010 
 
Primary Sponsor  
Name  KLE Academy of Higher Education and Research Belagavi 
Address  Univesity Internal Seed money grant for research, KLE Academy of Higher Education and Research Nehru Nagar Belagavi, Karnataka 560010 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajan R Patil  Dr. Prabhakar Kore Hosptial and Research Centre  Room 21, Department of Urology, Ist floor, Dr. Prabakar Kore Hospital, NEHARU NAGAR, BELGAUM 560010
Belgaum
KARNATAKA 
9445811610

rajanpatil@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of KLE Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N819||Female genital prolapse, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  None  None 
Comparator Agent  None  None 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  All non-pregnant women at the age of 15, married women (past & present) above consenting to participate in the study 
 
ExclusionCriteria 
Details  All pregnant women 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence of symptomatic pelvic organ prolapse   At the time of evaluation 
 
Secondary Outcome  
Outcome  TimePoints 
Urinary incontinence  At the time of evaluation 
Voiding dysfunction  At the time of evaluation 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Background

Pelvic organ prolapse (POP) is defined as “the descent of one or more aspects of the vagina and the uterus: the anterior vaginal wall, posterior vaginal wall, the uterus (cervix) or the apex of the vagina (vaginal vault or the cuff scare after hysterectomy. Women with early onset POP are generally asymptomatic while women with advanced POP often experience a palpable bulge in the vagina along with concurrent lower urinary tract and anorectal dysfunction. However, POP significantly affects women’s quality of life when the bulging interferes with normal sexual, urinary, or bowel function. Prevalence of POP is estimated to be 15% in low and middle-income countries.

Specific Aims:

Prevalence of symptomatic pelvic organ prolapse in women residing in Belagavi, India

Proportions of women who screen positive for prolapse associated pelvic floor dysfunction

a. Lower urinary tract dysfunction (urinary incontinence, voiding dysfunction)

b. Anorectal dysfunction (fecal incontinence, constipation syndromes)

c. Other

Current status of quality of life, awareness and knowledge, and care-seeking barriers among women with POP residing in Belagavi, India

Inclusion Criteria:

1.       All non-pregnant women at the age of 15 married women (past & present) above consenting to participate in the study.

Exclusion Criteria:

1.       All pregnant women.

Study Site: Women attending the community served by Primary Healthcare Centers (PHCs) managed by KAHER’s J N Medical College, Belagavi.

Sample size:

Estimated sample size 467 in the Belagavi catchment area based on prior  prevalence data and pilot study.

Methodology

1.       The study participants who screen positive for POP screening tool, will be provided with the option to undergo urogynecological examination by an obstetrics and gynecology resident, Urogynecology fellow, or obstetrician and gynecologist in a mobile unit, and will be referred for appropriate clinical management.

 
Close